An Infant Formula with Partially Hydrolyzed Whey Protein Supports Adequate Growth and Is Safe and Well-Tolerated in Healthy, Term Infants: A Randomized, Double-Blind, Equivalence Trial.

Nutrients
Jean-Charles Picaud On Behalf Of The Tenuto Study Group

Abstract

The current study evaluates the safety and tolerance of a partially hydrolyzed whey protein-based infant formula (PHF) versus an in intact cow's milk protein formula (IPF). Breastfed infants were included as a reference group. In a multi-country, multicenter, randomized, double-blinded, controlled clinical trial, infants whose mothers intended to fully formula feed were randomized to PHF (n = 134) or IPF (n = 134) from ≤14 days to 17 weeks of age. The equivalence analysis of weight gain per day within margins of +/-3 g/d (primary outcome), the recorded adverse events, growth and gastro-intestinal tolerance parameters were considered for the safety evaluation. Equivalence of weight gain per day from enrolment until 17 weeks of age was demonstrated in the PHF group compared to the IPF group (difference in means -1.2 g/d; 90% CI (-2.42; 0.02)), with estimated means (SE) of 30.2 (0.5) g/d and 31.4 (0.5) g/d, respectively. No significant differences in growth outcomes, the number, severity or type of (serious) adverse events and tolerance outcomes, were observed between the two formula groups. A partially hydrolyzed whey protein-based infant formula supports adequate infant growth, with a daily weight gain equivalent to a standard i...Continue Reading

References

Jun 29, 2001·Journal of Pediatric Gastroenterology and Nutrition·J C PicaudB L Salle
Dec 31, 2004·Journal of Pediatric Gastroenterology and Nutrition·Jan KnolJohn Wells
Oct 21, 2006·The Cochrane Database of Systematic Reviews·D A Osborn, J Sinn
Dec 5, 2008·The Journal of Pediatrics·Noor BekkaliMarc A Benninga
Apr 17, 2009·The American Journal of Clinical Nutrition·Peter RzehakUNKNOWN German Infant Nutritional Intervention Study Group
Sep 22, 2011·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·Betty C A M van EschJohan Garssen
Jan 4, 2012·Annals of Nutrition & Metabolism·Michael S Kramer
Nov 16, 2013·The Journal of Allergy and Clinical Immunology. in Practice·David M FleischerJacqueline A Pongracic
Apr 5, 2014·Allergy·A MuraroUNKNOWN EAACI Food Allergy and Anaphylaxis Guidelines Group
Oct 14, 2014·World Journal of Gastroenterology : WJG·Petra A M J ScholtensAnnamaria Staiano
Mar 10, 2016·BMJ : British Medical Journal·Robert J BoyleJo Leonardi-Bee
Jul 30, 2016·Journal of Pediatric Gastroenterology and Nutrition·Frédéric HuetJonathan O'B Hourihane
May 19, 2017·Annals of Nutrition & Metabolism·Wendy H Oddy
Dec 8, 2017·Journal of Pediatric Gastroenterology and Nutrition·Birgit AhrensKirsten Beyer
Oct 20, 2018·The Cochrane Database of Systematic Reviews·David A OsbornLisa J Jones
Dec 24, 2019·The American Journal of Clinical Nutrition·Stefanie M P KouwenhovenBerthold V Koletzko

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NCT03062761

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